Spine Wave, Inc.
FDA Regulatory Profile
Spine Wave, Inc. appears in FDA public data with 2 recalls, 59 510(k) clearances, 5 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1960-2015, Class II) was initiated on May 4, 2015. Its most recent 510(k) clearance was granted on June 15, 2026.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 59
- Inspections
- 5
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1960-2015 | Class II | Spine Wave Access Kit, Catalog Number 10-1530 Package contents: RLSP494-Rhythmlink Monopolar Stimul | May 4, 2015 |
| Z-2187-2013 | Class II | StaXx¿ IB Convex Expandable Implant (25 x 12 x 9 mm), Intervertebral Fusion Device, Lumbar; Catalog | May 14, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K260286 | Dynamo Spinal Cement; Salvo® Spine System | June 15, 2026 |
| K261159 | Exceed® Biplanar Expandable Interbody System | May 29, 2026 |
| K243816 | Testa TP Pivoting Spacer System | June 27, 2025 |
| K251131 | Annex® 2 Adjacent Level System | June 6, 2025 |
| K243514 | Salvo® Robotic Navigation Instruments | April 3, 2025 |
| K240685 | Salvo® Spine System | May 6, 2024 |
| K231275 | Exceed Biplanar Expandable Interbody System | July 25, 2023 |
| K222362 | Salvo® Spine System | August 29, 2022 |
| K202476 | Salvo® Spine System | November 5, 2020 |
| K192526 | Spine Wave Navigated Instruments | October 10, 2019 |
| K191045 | Salvo Spine System | July 10, 2019 |
| K182954 | Salvo Spine System | December 12, 2018 |
| K181596 | Spine Wave Navigated Instruments | October 24, 2018 |
| K181440 | Proficient® Posterior Cervical Spine System | July 30, 2018 |
| K172594 | Proficient® Posterior Cervical Spine System | December 15, 2017 |
| K173175 | Paramount Anterior Cervical Cage System | November 1, 2017 |
| K172175 | CapSure® PS System | August 16, 2017 |
| K163246 | Leva Anterior Expandable Spacer System | April 6, 2017 |
| K162760 | Spine Wave Anterior Cervical Spine System | February 16, 2017 |
| K162639 | Proficient Posterior Cervical Spine System | February 7, 2017 |